International recommendations for the assessment of autoantibodies to cellular antigens referred to as anti-nuclear antibodies. Issue 1 (14th October 2013)

• Record Type: Journal Article
• Authors: Agmon-Levin, Nancy; Damoiseaux, Jan; Kallenberg, Cees; Sack, Ulrich; Witte, Torsten; Herold, Manfred; Bossuyt, Xavier; Musset, Lucille; Cervera, Ricard; Plaza-Lopez, Aresio; Dias, Carlos; Sousa, Maria José; Radice, Antonella; Eriksson, Catharina; Hultgren, Olof; Viander, Markku; Khamashta, Munther; Regenass, Stephan; Andrade, Luis Eduardo Coelho; Wiik, Allan; Tincani, Angela; Rönnelid, Johan; Bloch, Donald B; Fritzler, Marvin J; Chan, Edward K L; Garcia-De La Torre, I; Konstantinov, Konstantin N; Lahita, Robert; Wilson, Merlin; Vainio, Olli; Fabien, Nicole; Sinico, Renato Alberto; Meroni, Pierluigi; Shoenfeld, Yehuda;
• Other Names: Tervaert JW Cohen author non-byline.; Hamann D author non-byline.; Derksen RHWM author non-byline.; Hooijkaas H author non-byline.; Klasen I author non-byline.; Limburg P author non-byline.; Smeenk R author non-byline.; van Daele P author non-byline.; Elvin Kerstin author non-byline.; Dahle Charlotte author non-byline.; Skogh Thomas author non-byline.; Antonen Jaakko author non-byline.; Haapala Anna-Maija author non-byline.; Hietarinta Marja author non-byline.; Häkkinen Teija author non-byline.; Hänninen Arno author non-byline.; Jokiranta Sakari author non-byline.; Karjalainen Anna author non-byline.; Laatikainen Aino author non-byline.; Leirisalo-Repo Marjatta author non-byline.; Luosujärvi Riitta author non-byline.; Miettinen Aaro author non-byline.; Siuro Jari author non-byline.; Sved Sune author non-byline.; Tuuminen Tamara author non-byline.; Walle Timo author non-byline.; Coelho Fátima author non-byline.; Santos Maria José author non-byline.; Bogas Mónica author non-byline.; Ramos João P author non-byline.; Faro-Viana João author non-byline.; Olsson Nils Olivier author non-byline.; Chyderiotis Georges author non-byline.; Bach-Nga author non-byline.; Aubert Vincent author non-byline.; Dahinden Clemens author non-byline.; Dayer Eric author non-byline.; Mascart Françoise author non-byline.; Tomasi Jean-Paul author non-byline.; Vercammen Martine author non-byline.; Verschueren Patrick author non-byline.; Houssiau Fréderic author non-byline.; Lauwerys Bernard author non-byline.; De Keyser Filip author non-byline.; Fierz Walter author non-byline.; Heijnen Ingmar author non-byline.; Keller Franco author non-byline.; Müllner Gerhard author non-byline.; Regenass Stephan author non-byline.; Roux-Lombard Pascale author non-byline.; Wirthmüller Urs author non-byline.; Gilburde Boris author non-byline.; Levi Rachel author non-byline.; Lipinsky Daphna author non-byline.; Barak Mira author non-byline.; Mahmud Abu-Shakra author non-byline.; Fishel Ruth author non-byline.; Foguel Mina author non-byline.; Shay Kivity author non-byline.; Csernok Elena author non-byline.; Schlüter Bernhard author non-byline.; Becker Bettina author non-byline.; Mierau Rudolf author non-byline.; Witte Torsten author non-byline.; Seidel Wolfram author non-byline.; Frank Ingrid author non-byline.; Kromminga Arno author non-byline.; Hiepe Falk author non-byline.; Conrad Karsten author non-byline.; Sticherling Michael author non-byline.; Steiner Guenter author non-byline.; Valentyna Chopyak author non-byline.; Alcalá Inmaculada author non-byline.; Alsina Montserrat author non-byline.; José Amengual María author non-byline.; Carrasco Ángela author non-byline.; Fernández Luis author non-byline.; Figueredo María Ángeles author non-byline.; Gelpí Carmen author non-byline.; Jiménez Juana author non-byline.; Juliá María Rosa author non-byline.; López-Hoyos Marcos author non-byline.; Mozo Lourdes author non-byline.; Muñoz Cecilia author non-byline.; Muñoz Francisco Javier author non-byline.; Palomino Pilar author non-byline.; Prada Álvaro author non-byline.; Hernandez Carmen Rodríguez author non-byline.; Roy Garbiñe author non-byline.; Ruiz Estibaliz author non-byline.; Vargas Luisa author non-byline.;
• Is Part Of: Annals of the rheumatic diseases. Volume 73:Issue 1(2014)
• Page Start: 17
• Page End: 23
• Publication Date: 2013-10-14
• Subjects: Autoantibodies -- Autoimmunity -- Systemic Lupus Erythematosus -- Sjøgren's Syndrome; Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2013-203863
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Anti-nuclear antibodies (ANA) are fundamental for the diagnosis of autoimmune diseases, and have been determined by indirect immunofluorescence assay (IIFA) for decades. As the demand for ANA testing increased, alternative techniques were developed challenging the classic IIFA. These alternative platforms differ in their antigen profiles, sensitivity and specificity, raising uncertainties regarding standardisation and interpretation of incongruent results. Therefore, an international group of experts has created recommendations for ANA testing by different methods. Two groups of experts participated in this initiative. The European autoimmunity standardization initiative representing 15 European countries and the International Union of Immunologic Societies/World Health Organization/Arthritis Foundation/Centers for Disease Control and Prevention autoantibody standardising committee. A three-step process followed by a Delphi exercise with closed voting was applied. Twenty-five recommendations for determining ANA (1–13), anti-double stranded DNA antibodies (14–18), specific antibodies (19–23) and validation of methods (24–25) were created. Significant differences between experts were observed regarding recommendations 24–25 (p<0.03). Here, we formulated recommendations for the assessment and interpretation of ANA and associated antibodies. Notably, the roles of IIFA as a reference method, and the importance of defining nuclear and cytoplasmic staining, were emphasised, while the need to incorporate alternative automated methods was acknowledged. Various approaches to overcome discrepancies between methods were suggested of which an improved bench-to-bedside communication is of the utmost importance. These recommendations are based on current knowledge and can enable harmonisation of local algorithms for testing and evaluation of ANA and related autoantibodies. Last but not least, new more appropriate terminologies have been suggested.